Alnylam Pharmaceuticals has completed the rolling submission of the New Drug Application for Givosiran to the Food and Drug Administration (FDA). This announcement comes only 90 days after Alnylam reported topline results of the ENVISION Phase 3 study. Givosiran is an investigational RNAi for the treatment of acute porphyria. Givosiran has also been granted Priority Medicines (PRIME) Designation by the European Medicines Agency (EMA) and Orphan Drug Designation in the EU for AHP. Alnylam intends to file a Marketing Authorisation Application (MAA) in mid-2019.
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The entire press release can be found here.